Manager PV Standards Quality Training & Compliance

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.

We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue's Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.

At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!

EMPLOYER: Purdue Pharma L.P.

TITLE: Manager, PV Standards Quality Training & Compliance

LOCATION: One Stamford Forum, 201 Tresser Boulevard, Stamford, CT 06901

DUTIES:

Examine, evaluate, and investigate conformity with pharmacovigilance regulatory requirements and perform other compliance and analysis activities. Coordinate and document internal regulatory processes. Contribute to the establishment of procedures and processes that ensure compliance of the company-wide pharmacovigilance (PV) system with Purdue's legal PV obligations both as Marketing Authorization Holder and Sponsor of clinical trials. Track compliance with pharmacovigilance regulatory requirements, including system performance. Ensure that adequate corrective and preventative action (CAPA) plans are installed where needed and are timely completed. Provide support to the development of written procedures to ensure that the PV system is compliant with governing regulations and adequately described in Quality Management System documents. Support PV related audits and authority inspections. Provide input to annual PV Audit Plan. Review internal and external audit and inspection reports and identify areas needing corrective and/or preventive actions. Monitor changes and new developments in regulatory pharmacovigilance requirements globally and provide support in assessing and implementing the potential impact of such changes and developments. Provide PV specific training for Purdue personnel and key vendors. Full-time telework permitted from CT, NJ, NY, NC, MA, FL, PA, TX, CA, DE, VT, DC, ME, MD, VA, NH, MO, AZ, and OH.

REQUIREMENTS:

Bachelor's degree in Healthcare, Public Health, or a directly related field and 3 years of experience in the job offered or related pharmacovigilance or drug safety occupation. Must have 3 years of experience with: Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines; PV audits and global inspections; training management and Procedural life- cycle management; PV obligations for sponsors of clinical trials; and developing and managing CAPA plans.

SALARY: $102,500 - $150,500/year.

TO APPLY Send resume to careers@pharma.com and reference code 18595.00075

We respect diversity and accordingly are an equal opportunity and an affirmative action employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• Equal Employment Opportunity is the Law (EEO)
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• Pay Transparency Nondiscrimination Provision (Spanish)

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Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.

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